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Regulatory Support Technician

Regulatory Support Technician

Leiters IncEnglewood, CO, US
30+ days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Regulatory Support Technician

This position will report directly to the Pharmacist-in-Charge or Pharmacist Supervisor. The regulatory support technician will work collaboratively with pharmacists, shipping and inventory control personnel, customer experience personnel, and Quality Assurance. They will aid in the completion of requirements set forth by the FDA for a 503B Outsourcing Facility and per company policies and procedures.

Why Join Leiters Health?

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team!

At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.

  • Innovative Culture : Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
  • Meaningful Work : Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
  • Professional Development : Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
  • Cutting-Edge Technology : Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
  • Collaborative Environment : Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

Who We're Looking For :

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!

Essential Functions :

  • Ensure compliance with all federal, state, and local regulations related to support activities
  • Review and verify documentation performed by shipping and inventory personnel, customer experience personnel, and other support staff for completeness, accuracy, and adherence to cGMPs
  • Perform DEA report writing and recordkeeping duties
  • Participate in customer audits as necessary
  • Work collaboratively with members from various teams to achieve company goals
  • Perform printing, scanning, and filing of documents as needed

    • Experience & Necessary Skills :

  • High school diploma or GED required
  • Familiarity & comprehension of regulations including DEA, DQSA, 21 CFR 211 and USP guidelines, as applicable, is preferred
  • cGMP and / or pharmaceutical industry experience preferred
  • Good IT skills, including but not limited to Word, Excel, PowerPoint and use of licensed software applications
  • Excellent interpersonal and communication skills, both verbal and written
  • Ability to assume responsibility and act on own initiative
  • Good self-management, organizational and planning skills
  • Ability to adhere to strict deadlines and procedures
  • Excellent reasoning and critical thinking skills
  • Hands-on approach with a “can-do” attitude
  • Good listener, but proactive in group discussions
  • Able to lift up to 50 lbs, stand for extended periods of time when required
  • Must pass English Competency Test

    • Benefits :

  • 100% employer paid medical plan.
  • Dental & Vision insurance options including FSA & HSA
  • Employer Paid Life Insurance & Employee Assistance Program
  • Short Term & Long-Term Disability Insurance
  • Up to 4% 401K Matching (100% vested on day one!)
  • Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
  • 5,250 Annual Tuition Reimbursement after 6 months
  • 1,000 Referral Bonus Program with no limit
  • Eligible for annual bonus program

    • Shift : Monday-Friday

    Timeline :  We will be accepting applications on an ongoing basis until position is filled.

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

  • Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.